CN103002800A - Wearable mobile medical device with multiple sensing electrodes - Google Patents

Abstract

An ambulatory medical device includes a plurality of electrodes configured to be disposed at spaced locations around a patient's body, an electrode signal acquisition circuit, and a monitoring circuit. The acquisition circuit has a plurality of inputs each electrically coupled to a respective electrode of the plurality of electrodes and is configured to sense a respective signal provided by a plurality of different pairs of the plurality of electrodes. The monitoring circuit is electrically coupled to an output of the acquisition circuit and configured to analyze the respective signal provided by each of the plurality of different pairs and instruct the acquisition circuit to select at least one of the plurality of different pairs to monitor based on at least one of a quality of the respective signal, a phase difference between the respective signal and a respective signal of another pair, and other criteria.

Description

Wearable portable medical device with a plurality of sensing electrodes

The cross reference of related application

The application requires to submit on May 18th, 2010 according to 35U.S.C. § 119 (e), name is called " the wearable portable medical device (WEARABLE AMBULATORYMEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES) with a plurality of sensing electrodes ", serial number is 61/345,914 U.S. Provisional Application and submitted in 17th in December in 2010, name is called " the wearable portable medical device (WEARABLE AMBULATORYMEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES) with a plurality of sensing electrodes ", serial number is 61/424, the priority of 344 U.S. Provisional Application, each of above-mentioned application intactly is incorporated in herein by reference.

Technical field

The present invention relates generally to the cardiac function that detects the patient, and relates more particularly to detect in such as the portable medical device of wearable defibrillator cardiac function and treatment heart.

Background technology

Use obtains patient's electrocardiogram (ECG) signal such as the portable medical device of the wearable defibrillator of being dressed by mobile patient from body surface electrodes.When obtaining the ECG signal in this mode, electrical noise or electrode come off and often reduce the quality of ECG signal.This challenge becomes from the challenge of the clean ECG signal of the sometimes noisy signal extraction of being derived by body surface electrodes.

Electrode noise can be slided and causes at patient's health by patient's the caused electrode of hyperkinesia (for example strenuous exercise).Noise also can be by allowing electrode along with small patient moving misfits electrode shroud or clothes and causes what patient's health slided.Electrode comes off to be lost in health upset and with health by electrode and contact or from body lift and lose and contact and cause.Even correctly be positioned at electrode in the situation on patient's the health, the skin of overdrying also can cause noise.

The wearable defibrillator of known movement (for example can obtain from the Zoll medical company in Massachusetts Qie Muside city (Chelmsford)

Wearable cardioverter defibrillator) uses four ECG sensing electrodes that dispose with the dual pathways.Namely, by signal of telecommunication that provides in four ECG sensing electrodes with match to form passage by another signal of telecommunication that provides in four ECG sensing electrodes.This layout of ECG sensing electrode is normally suitable, reason be as a rule noise or electrode movement to affect whole physical environment be rare.It is redundant and in case of necessity that dual pathways configuration provides, when one in the passage because the ECG sensing electrode comes off or because the signal to noise ratio that differs from when declaring to use, the permission system operates with single channel.Because signal quality is also different between the patient, therefore having two passages provides the chance of improving picking up signal, and reason is that the ECG sensing electrode is positioned at different body positions.Two channel systems also allow the analysing ECG signal to determine heart, such as United States Patent (USP) the 5th, 944, described in 669.

The problem of the existing electrode system that uses in portable medical therapy equipment (for example wearable defibrillator) is still to have on two passages all noisy situations.When noise being arranged or come off, device gives the alarm and corrects this problem so that the patient can take action.Use noise ECG signal, the arrhythmia detection algorithm meeting " mistake " in the wearable defibrillator device is arrhythmia with noise measuring, causes thus device to send the treatment sequence, if do not stopped by the patient, described treatment sequence may be carried non-essential electric shock.

Summary of the invention

Embodiments of the invention relate to a kind of wearable medical monitoring device and/or a kind of wearable medical monitoring and therapy equipment, and it comprises and is arranged in around a plurality of ECG sensing electrodes of the different axial locations of patient's health and can selects greatly to improve the quality of the ECG signal that is obtained from a plurality of passages corresponding to the difference pairing of those a plurality of ECG sensing electrodes.The ECG sensor signal of this improvement can be used for noise decrease, the quantity of the alarm that reduces to come off, the quantity of the false detection of cardiac arrhythmia or above whole that reduces.

According to an aspect of the present invention, provide a kind of portable medical device.In one embodiment, described portable medical device comprises a plurality of electrodes, electrode signal Acquisition Circuit and the observation circuit that is configured to be arranged in around the interval location of patient's health.Described electrode signal Acquisition Circuit has a plurality of inputs, and the corresponding input of each of described a plurality of inputs is electrically coupled to the respective electrode of described a plurality of electrodes.Described electrode signal Acquisition Circuit is configured to sensing by a plurality of different corresponding signals that provide that match of described a plurality of electrodes.Described observation circuit is electrically coupled to the output of described electrode signal Acquisition Circuit.Described observation circuit is configured to analyze by each corresponding signal that provide of described a plurality of different pairings and indicates described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one to monitor based on following at least one: by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings, by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings, selecteed at least one respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least one the respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.

According to an embodiment, described portable medical device also comprises the clothes that is configured to around patient's health wearing, and described a plurality of electrode is incorporated in the described clothes.According to another embodiment, described a plurality of electrodes are ECG sensing electrodes, and described observation circuit is cardiac monitoring and arrhythmia detection circuit.

In one embodiment, described a plurality of ECG sensing electrode comprises at least three ECG sensing electrodes.In another embodiment, described a plurality of ECG sensing electrode all is not arranged in common plane.

In one embodiment, described cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings.Another aspect according to this embodiment, described portable medical device also comprises a plurality of therapeutic electrodes, described a plurality of therapeutic electrode is incorporated in the described clothes, and is configured to respond by described cardiac monitoring and arrhythmia detection electric circuit inspection to the health that can treat cardiac arrhythmia defibrillation shock is transported to the patient.

According to another embodiment, described cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by the plane that selecteed at least one the respective electrode in described a plurality of different pairings limits.

In another embodiment, described cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, to monitor with respect to the cardiac cycle of the position of patient's health and patient's heart based on selecteed at least one the respective electrode in described a plurality of different pairings.

In alternative, described cardiac monitoring and arrhythmia detection circuit are configured to select in described a plurality of different pairings at least three to monitor based on following at least one: by the quality of each selecteed at least three corresponding signal that provides in described a plurality of different pairings, by the phase contrast between each selecteed at least three corresponding signal that provides in described a plurality of different pairings, selecteed at least three respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least three respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.

In one embodiment, described a plurality of electrode comprises at least four ECG sensing electrodes that all are not arranged in common plane.

According to an embodiment, described observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings.

According to another embodiment, described observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by the plane that selecteed at least one the respective electrode in described a plurality of different pairings limits.

According to another embodiment, described observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, to monitor with respect to the cardiac cycle of the position of patient's health and patient's heart based on selecteed at least one the respective electrode in described a plurality of different pairings.

According to an embodiment, described observation circuit is configured to select in described a plurality of different pairings at least three to monitor based on following at least one: by the quality of each selecteed at least three corresponding signal that provides in described a plurality of different pairings, by the phase contrast between each selecteed at least three corresponding signal that provides in described a plurality of different pairings, selecteed at least three respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least three respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.According to another embodiment, described observation circuit is configured to during the first period to select different at least two among at least two selecteed at least three of monitoring and selecting during the second period in described a plurality of different pairings among in described a plurality of different pairings selecteed at least three to monitor.

In one embodiment, described a plurality of ECG sensing electrode comprises at least three ECG sensing electrodes.

According to an embodiment, described electrode signal Acquisition Circuit comprises selects circuit and a plurality of differential amplifier.Described selection circuit has a plurality of inputs and a plurality of output, and the corresponding input of each of described a plurality of inputs of described selection circuit is electrically coupled to the respective electrode of described a plurality of electrodes.The corresponding differential amplifier of each of described a plurality of differential amplifiers has a pair of input and an output, the corresponding input of each of described a pair of input is electrically coupled to the corresponding output of described a plurality of outputs of described selection circuit, and the corresponding output of each of described a plurality of differential amplifiers provides the output signal corresponding to the difference between the described a pair of input of described corresponding differential amplifier.

According to another embodiment, wherein said electrode signal Acquisition Circuit comprises a plurality of differential amplifiers and selects circuit that described a plurality of differential amplifiers comprise the corresponding differential amplifier for each unique pairing of described a plurality of electrodes.In this embodiment, described selection circuit be configured to select described a plurality of differential amplifiers at least one export to offer described observation circuit.

According to another embodiment, described electrode signal Acquisition Circuit comprises analog multiplexer and analog-digital converter.Described analog multiplexer has a plurality of inputs and an output, and each of described a plurality of inputs is electrically coupled to corresponding in described a plurality of electrode, and described analog-digital converter has the input of the output that is electrically coupled to described analog multiplexer.According to the aspect of this embodiment, the sample rate that described analog-digital converter has is that by at least N of the expectation sample rate of each signal that provides of described a plurality of electrodes doubly wherein N is the quantity with monitored described a plurality of electrodes.Another aspect according to this embodiment, described observation circuit comprises at least one processor, described at least one processor is configured to receive corresponding to the first digital signal of the first electrode of described a plurality of electrodes with corresponding to the second digital signal of the second electrode of described a plurality of electrodes, in anti-phase described the first and second digital signals one, and another in described anti-phase and described the first and second digital signals in described the first and second digital signals of suing for peace, the corresponding signal that provides with the pairing of analyzing by described the first electrode and described the second electrode.

According to another embodiment, described electrode signal Acquisition Circuit comprises a plurality of analog-digital converters, and each corresponding analog-digital converter has corresponding one the corresponding input that is electrically coupled in described a plurality of electrode.In one embodiment, each of described a plurality of analog-digital converters is connected in described a plurality of analog-digital converter another by universal serial bus.

A kind of method of the ECG of monitoring signal is provided according to another aspect of the present invention.In one embodiment, described method comprises a plurality of different pairings of selecting the ECG sensor among a plurality of ECG sensors; Analysis is by each corresponding ECG signal that provides of described a plurality of different pairings; Identify in described a plurality of different pairings at least one to monitor based on following at least one: the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings, the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by the phase contrast between another at least one the corresponding ECG signal that provides that is identified in described a plurality of different pairings, the corresponding ECG sensor of described at least one that is identified in described a plurality of different pairings is with respect to the position of patient's health, by the plane of the corresponding ECG sensor definition of described at least one that is identified in described a plurality of different pairings, and the cardiac cycle of patient's heart; And monitor described at least one that is identified in described a plurality of different pairings.

According to an embodiment, identify at least one action to monitor in described a plurality of different pairings, the corresponding ECG signal that provides based on the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by described at least one that is identified in described a plurality of different pairings and by the phase contrast between another at least one the corresponding ECG signal that provides that is identified in described a plurality of different pairings.

In one embodiment, select among described a plurality of ECG sensors the actions of a plurality of different pairings of ECG sensor to comprise among described a plurality of ECG sensors and select the action of each unique pairing of ECG sensor, and action by each corresponding ECG signals that provide of described a plurality of different pairings is provided is comprised and analyze the corresponding ECG signal that each the unique pairing by the ECG sensor provides.

In another embodiment, the action of monitoring comprises that described at least one that is identified of monitoring in described a plurality of different pairings is to detect cardiac arrhythmia.According to an embodiment, described method also comprises following action: the motion detection cardiac arrhythmia of response monitoring; Determine that detected cardiac arrhythmia is the type of the cardiac arrhythmia that can treat by the health that defibrillation is applied to the patient; And the health that at least one defibrillation pulse is applied to the patient.

In another embodiment, described method also comprises following action: the motion detection cardiac arrhythmia of response monitoring; Response detects cardiac arrhythmia and selects at least one additional pairing of ECG sensor and the corresponding ECG signal that is provided by described at least one additional pairing is provided; Determine that detected cardiac arrhythmia also is present on the corresponding ECG signal of described at least one additional pairing; Determine that detected cardiac arrhythmia is the type of the cardiac arrhythmia that can treat by the health that defibrillation is applied to the patient; And the health that at least one defibrillation pulse is applied to the patient.

In alternative, described method also comprises following action: the motion detection cardiac arrhythmia of response monitoring; Response detects cardiac arrhythmia and selects at least one additional pairing of ECG sensor and the corresponding ECG signal that is provided by described at least one additional pairing is provided; Determine that detected cardiac arrhythmia also is present on the corresponding ECG signal of described at least one additional pairing; And increase has detected the confidence level of cardiac arrhythmia.

In another embodiment, described method also comprises following action: the motion detection cardiac arrhythmia of response monitoring; Response detects cardiac arrhythmia and selects at least one additional pairing of ECG sensor and the corresponding ECG signal that is provided by described at least one additional pairing is provided; Determine that detected cardiac arrhythmia is not present on the corresponding ECG signal of described at least one additional pairing; And the confidence level that reduces to detect cardiac arrhythmia.

According to an embodiment, repeat the action of described selection, analysis and identification with periodic intervals.

According to another embodiment, described a plurality of ECG sensors are incorporated in the clothes of patient's health wearing, and carry out the action of described selection, analysis and identification when described clothes centers on patient's health placement.

According to another embodiment, wherein said a plurality of ECG sensor is incorporated in the clothes of patient's health wearing, described method also comprises the action of the violent body movement that detects the patient, and the action of response detection patient's aggravating activities repeats the action of described selection, analysis and identification.

According to another embodiment, described method also comprises following action: the quality of determining the corresponding ECG signal that the first pairing by the ECG sensor of described at least one that is identified in described a plurality of different pairings provides is lower than definite threshold; Select the first pairing of another pairing replacement ECG sensor of ECG sensor; And another pairing of monitoring ECG sensor.

According to another embodiment, described method also comprises following action: the quality of the corresponding ECG signal that the first pairing of the ECG sensor of described at least one that is identified from matched by described a plurality of differences provides determines that one or more may the losing with patient's health at least in part in the described first ECG sensor that matches contacts; Select the first pairing of another pairing replacement ECG sensor of ECG sensor; And another pairing of monitoring ECG sensor.

According to an embodiment, identify in described a plurality of different pairings at least one with the action of monitoring based on the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by the plane of the corresponding ECG sensor definition of described at least one that is identified in described a plurality of different pairings.

According to another embodiment, identify in described a plurality of different pairings at least one with the action of monitoring based on the corresponding ECG sensor of described at least one that is identified in the described a plurality of different pairings cardiac cycle with respect to the position of patient's health and patient's heart.

The below has discussed other aspect, embodiment and the advantage of these illustrative aspects and embodiment in detail.And, be to be understood that aforementioned information and following detailed description only are the illustrative example of each aspect of the present invention and embodiment, and aim to provide general introduction or framework be used to character and the feature of the aspect of understanding prescription and embodiment.Any embodiment disclosed herein can be with any mode and any other embodiment combination of at least one aspect of meeting invention disclosed herein, and mentions that " embodiment ", " some embodiment ", " alternative ", " each embodiment ", " embodiment ", " at least one embodiment ", " this and other embodiment " etc. are not necessarily mutually exclusive and be intended to indicate special characteristic, structure or the characteristic described in conjunction with this embodiment to comprise at least one embodiment.The appearance of such term herein not necessarily all represents identical embodiment.In addition, in the document be incorporated in by reference that term uses in the inconsistent situation between herein the document, it is replenishing of the document that the term in the merged list of references uses; Inconsistent for contradiction, the term in the document use account for leading.

Description of drawings

Accompanying drawing is not intended to draw in proportion.In the accompanying drawings, represented by similar Reference numeral in the identical or approximate same parts of each shown in each figure.For the sake of clarity, may in each accompanying drawing, not indicate each parts.In the accompanying drawings:

Figure 1A shows the electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes are incorporated in the clothes (for example shirt or vest) on the health that can be worn on the patient, and wherein electrode is arranged in patient's the plane of heart substantially;

Figure 1B shows the alternate electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes for example are incorporated in the clothes shown in Figure 1A, but wherein electrode distributes around patient's trunk;

Fig. 1 C shows the alternate electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes are incorporated in the clothes (for example shroud) on the health that can be worn on the patient, and wherein electrode is arranged in patient's the plane of heart substantially;

Fig. 1 D shows the alternate electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes are incorporated in the clothes (for example shroud) on the health that can be worn on the patient, and wherein electrode distributes around the part of patient's trunk;

Fig. 1 E shows another alternate electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes are incorporated in the clothes (for example braces), and wherein electrode distributes around patient's trunk;

Fig. 1 F shows the alternate electrode system of portable medical device, and wherein a plurality of ECG sensing electrodes directly are attached to patient's trunk;

Fig. 1 G shows the plane graph of the electrode system of Figure 1A-F;

Fig. 2 A shows the electrode signal Acquisition Circuit of the pairing that those electrodes that embodiments of the invention differentiate with the phase place of selecting maximization signal to noise ratio and maximization to be provided by electrode can be provided among a plurality of different pairings of ECG sensing electrode;

Fig. 2 B shows electrode signal Acquisition Circuit according to another embodiment of the invention, this electrode signal Acquisition Circuit is similar to the electrode signal Acquisition Circuit of Fig. 2 A, but comprises the one or more abilities as driving ground electrode that allow in the ECG sensing electrode;

Fig. 2 C shows electrode signal Acquisition Circuit according to another embodiment of the invention, and this electrode signal Acquisition Circuit is similar to the electrode signal Acquisition Circuit of Fig. 2 B, and allows one or more being used as in the ECG sensing electrode to drive ground electrode;

Fig. 3 shows the alternate electrode signal acquisition circuit that can be used for embodiments of the invention;

Fig. 4 is the functional block diagram that can be used for the control unit of embodiments of the invention;

Fig. 5 is the flow chart of the electrode selection course that can be carried out by at least one processor of the control unit of Fig. 4;

Fig. 6 is the flow chart of the noise that can be carried out by at least one processor of the control unit of Fig. 4/testing process that comes off;

Fig. 7 is the monitoring that can be carried out by at least one processor of the control unit of Fig. 4 and the flow chart of analysis routines;

Fig. 8 is the alternative monitoring that can be carried out by at least one processor of the control unit of Fig. 4 and the flow chart of analysis routines;

Fig. 9 shows another alternative signal Acquisition Circuit that can be used for embodiments of the invention;

Figure 10 shows another alternative signal Acquisition Circuit that can be used for embodiments of the invention; And

Figure 11 shows another alternative signal Acquisition Circuit that can be used for embodiments of the invention.

The specific embodiment

The present invention is not limited to set forth in the following description or the structure of parts illustrated in the accompanying drawings and the details of layout in its application.The present invention can have other embodiment and implement in every way or realization.And the word of using in this article and term are not to be regarded as restriction in order to describe." comprise " in this article, the use of " comprising ", " having ", " containing ", " relating to " and modification thereof represents to comprise item and equivalent and the addition Item of listing thereafter.

Intactly be incorporated in by reference herein United States Patent (USP) and described a kind of method and apparatus of the cardiac function for the sensing patient for the 5th, 944, No. 669, it can be used for starting the treatment of detected heart.The ECG sensing electrode be used for to obtain from the ECG signal of patient's heart and uses those ECG signals of various technical Analysis with the information of the operation of heart that the indication patient is provided, and whether there is a medicable heart, should start treatment, for example defibrillation for described heart.As described therein, use a plurality of right of ECG sensing electrode, so that can be compared to each other to improve reliability or detection from the difference of ECG sensing electrode to the signal that receives, so that can identify the noise that is present on one or more in the electrode, even so that also can provide monitoring in the situation that one or more in sensing electrode come off etc.

Embodiments of the invention relate to and can be used, for example, in United States Patent (USP) the 5th, electrode system in the wearable medical treatment device described in 944, No. 669 (be called as hereinafter " ' 699 patents ") with the monitoring cardiac function, start the treatment of detected heart or both have concurrently.As following described in more detail, although mainly aspect the signal of a plurality of ECG sensing electrodes, described embodiments of the invention in monitoring, should understand described technology herein and can easily expand sensor for other type except the ECG sensing electrode.For example, the sensor of other type can comprise activity sensor (such as the multiaxis accelerometer), pulse oximetry sensor, temperature sensor, respiration rate sensor, transthoracic impedance sensor, pressure transducer, sonic transducer etc.

As shown in Figure 1A, in one embodiment of the invention,electrode system 100 comprise be arranged in around the different axial locations of patient's health and be incorporated intoclothes 20a(for example shirt or vest on the trunk that is worn on the patient) in a plurality of ECG sensing electrodes 10.Shown in (and among Figure 1B-1F) among Figure 1A, those ECG arrangement of electrodes that show with full lines are in the front of patient's health, and those ECG arrangement of electrodes that show with dashed line form are at the back side of patient's health.Do not illustrate in the drawings although should understand, a plurality of ECG sensing electrodes 10 will comprise the electrode of the side of the health that is arranged in the patient substantially, and the electrode of front and back that is arranged in patient's health.

A plurality of ECG sensing electrodes 10 can be to disperse, do sense capacitance or conductive electrode, and described electrode for example is attached to clothes 20a by binding agent or loop fasteners, magnetically is attached to clothes 20a, or alternatively, is sewn onto among the clothes 20a.Also alternatively, in the ECG sensing electrode some or all can be formed by the conductor wire that is sewn onto among the clothes 20a, for example as submitted on May 17th, 2011, attorney docket is Z2011-700510, name is called " wearable therapy equipment (WEARABLE THERAPEUTIC DEVICE) ", serial number is 13/109, described in 079 the U.S. Patent application, above-mentioned application intactly is incorporated in herein by reference.Should understand the ECG sensing electrode or the attachment method that the invention is not restricted to particular type, reason is to use the various types of ECG sensing electrodes that comprise wet ECG sensing electrode, and comprises that binding agent is attached to the various attachment method of patient's health.And, although relate generally to be electrically coupled to by silk thread the ECG sensing electrode of control unit embodiments of the invention have been described, but really not so restriction the present invention, reason is the ECG sensing electrode that embodiments of the invention also can be used for use wireless communication interface and agreement (such as bluetooth, Wireless USB, ZigBee, wireless ethernet, GSM etc.) to communicate by letter with control unit, as following further as described in.

As shown in Figure 1A, a plurality of ECG sensing electrodes 10 are deployed in the interval axial location on the plane of the heart that is arranged in substantially the patient around patient's health.According to one embodiment of present invention, ECG sensing electrode 10 around patient's health to be incorporated into clothes 20a(for example shirt or vest) in substantially relative electrode pair (for example, ECG sensing electrode 10a, 10b) dispose, but really not so restriction the present invention.Should understand can change a plurality of ECG sensing electrodes 10 the position to avoid placing it can impel the uncomfortable position of patient at electrode, for example directly place on patient's the spinal column.Insulated conductor 15 is electrically coupled to control unit 30 with each ECG sensing electrode of a plurality of ECG sensing electrodes 10, and described control unit for example can comprise the signal acquisition circuit in greater detail below about Fig. 2 A-C, 3,9,10 and 11.Although do not show that each of insulated conductor 15 can be electrically connected to the adapter in the container that is received in control unit 30.Control unit 30 can be attached to clothes 20a, is attached to shroud, is received in the leather sheath or is attached to clip so that it can easily be dressed by the patient, and perhaps control unit 30 can be carried by the patient with any other suitable way.As shown in the figure, electrode system 100 also comprises at least one the driving ground electrode 12 that is attached to clothes 20a and is electrically coupled to control unit 30 by insulated conductor 18.Whether at least one drives ground electrode 12 and can use impact and/or detection ECG sensing electrode with noise decrease to come off in the mode described in the patent of ' 669.Be to eliminate the effect of noise first-selection although drive the use of ground electrode, should understand electrode 12 and need not be active drive, and can be passive circuit ground simply.

Figure 1B shows the electrode system 100 according to alternative of the present invention, and wherein a plurality of ECG sensing electrodes 10 are incorporated into clothes 20a(for example shirt or the vest on the trunk that is worn on the patient again) in.Yet in the embodiment shown in Figure 1B, a plurality of ECG sensing electrodes 10 distribute around patient's trunk, rather than are arranged in substantially the plane of patient's heart.With the same among the embodiment of Figure 1A, a plurality of ECG sensing electrodes 10 do not show wherein whole by respective electrical insulated conductor 15(in order to be easy to diagram) be electrically coupled to control unit 30, but can alternatively use wireless ECG sensing electrode.Electrode system 100 also comprises at least one the driving ground electrode 12 that is attached to clothes 20a and is electrically coupled to control unit by insulated conductor 18.Drive ground electrode 12 although only show in the drawings one, should understand and to use a plurality of driving ground electrodes.For example, can provide a plurality of driving ground electrodes, drive some pairing that is used for the ECG sensing electrode in the ground electrode, and drive another other pairing for the ECG sensing electrode in the ground electrode.And in certain embodiments, at least one driving ground electrode can switch to the difference pairing for the ECG sensing electrode.For example, if determine to drive that in the ground electrode one has come off or bad with patient's Body contact, then can change into using and drive in the ground electrode another.

A plurality of ECG sensing electrodes 10 can be disposed with relative substantially electrode pair (for example,ECG electrode 10a, 10b), and are perhaps spaced apart around patient's trunk simply.Although do not show in Figure 1B, a plurality of ECG sensing electrodes 10 can comprise first group of electrode of the interval axial location on the plane that is arranged in the heart that is positioned at substantially the patient, and are positioned at around second group of the electrode of the diverse location of patient's trunk.As following further described in more detail, the existence that all jointly is not positioned at the ECG sensing electrode in patient's the plane of heart allows to select can be corresponding to the different pairings of the ECG sensing electrode of the Different Plane of intersecting from patient's heart.And although not shown in Figure 1B, a plurality of ECG sensing electrodes 10 can comprise the ECG sensing electrode of the side of the trunk that is positioned at the patient and patient's front and back.Because the embodiment of Figure 1B roughly is similar to the embodiment of Figure 1A, therefore omit the further discussion of those common elements of two embodiment at this.

Fig. 1 C shows electrode system 100 according to another embodiment of the invention, wherein from Figure 1A in equally a plurality of ECG sensing electrodes 10 again be arranged in around the different axial locations of patient's health and be arranged in substantially the plane of patient's heart.Yet in the embodiment shown in Fig. 1 C, a plurality of ECG sensing electrodes 10 are incorporated into for example shroud of the clothes 20b(that dresses around patient's trunk) in.The same with the electrode system of Figure 1A and 1B, the electrode system 100 of Fig. 1 C can comprise the ECG sensing electrode of any type, for example discrete, do sense capacitance or conductive electrode, it is attached to clothes 20b, magnetically is attached to clothes 20b or be sewn onto among the clothes 20b by binding agent or securing member.The same with the embodiment of Figure 1A and 1B, a plurality of ECG sensing electrodes 10 can be disposed with relative substantially electrode pair (for example, ECG electrode 10a, 10b) around patient's health, perhaps simply around patient's trunk interval axially.Wire 15(does not show wherein whole in order to be easy to diagram) control unit 30 that each ECG sensing electrodes of a plurality of ECG sensing electrodes 10 is electrically coupled on the health that can be worn on the patient or carried by patient's health.Should understand and alternatively to use wireless ECG sensing electrode.About the same among Figure 1A and the described embodiment of 1B, the electrode system 100 of Fig. 1 C also comprised at least one the driving ground electrode 12 that is attached to clothes 20b and can whether have come off for impact and/or the detection ECG sensing electrode of noise decrease with before.At least one drives ground electrode 12 and can be arranged in the plane identical with a plurality of ECG sensing electrode 10, perhaps can be arranged in Different Plane.In certain embodiments, at least one drives ground electrode 12 also can be as therapeutic electrode with the heart with the shock administration patient, as about Fig. 1 E below further as described in.Although not shown in Fig. 1 C, a plurality of ECG sensing electrodes 10 can comprise the ECG sensing electrode of the side of the trunk that is positioned at the patient and patient's front and back.

Fig. 1 D showselectrode system 100 according to still another embodiment of the invention, wherein a plurality of ECG sensing electrodes 10 are incorporated into theclothes 20b(shroud for example on the trunk that is worn on the patient again) in, but wherein a plurality of ECG sensing electrodes 10 distribute around patient's trunk more widely.With the same among the embodiment of Figure 1A-C, a plurality of ECG sensing electrodes 10 do not show wherein whole by respective electrical insulated conductor 15(in order to be easy to diagram) be electrically coupled to controlunit 30, andelectrode system 100 comprises that also at least one drives ground electrode 12.At least one drivesground electrode 12 can comprise that being arranged in substantially first in the plane identical with a plurality of ECG sensing electrodes drives ground electrode, and is arranged in the driving of second in Different Plane ground electrode.A plurality of ECG sensing electrodes 10 in couples (for example,ECG electrode 10a, 10b) are disposed, and are perhaps spaced apart around patient's trunk simply.Because the embodiment of Fig. 1 D roughly is similar to the embodiment of Figure 1A-C, therefore omit the further discussion of those elements identical with Figure 1A-C at this.

Fig. 1 E shows theelectrode system 100 according to alternative of the present invention, and wherein a plurality of ECG sensing electrodes 10 are incorporated among theclothes 20c again.Yet in this embodiment,clothes 20c is for example to exist

The formal construction of the braces that uses in the wearable cardioverter defibrillator.Braces comprises and allows easily to regulate braces to be fit toscalable shroud 110 and thescalable shoulder tape 120 of different builds and body sizes.

As shown in Fig. 1 E, a plurality of ECG sensing electrodes 10 are arranged in along theshroud 110 ofclothes 20c and the diverse location ofshoulder tape 120 around patient's health.The same with previous described embodiment, a plurality of ECG sensing electrodes 10 can be to disperse, do sense capacitance or conductive electrode, described electrode is for example by binding agent, be attached toclothes 20c by loop fasteners or by stitching, perhaps alternatively, described electrode can be formed by the conductor wire that is sewn onto among the clothes 20c.The same with previous described embodiment, a plurality of ECG sensing electrodes 10 can be disposed with relative substantially electrode pair (for example,ECG sensing electrode 10a and 10b), perhaps alternatively, can not dispose in couples, but be arranged in simply around each position of patient's health.Although not shown in Fig. 1 E, a plurality of ECG sensing electrodes 10 will comprise the ECG sensing electrode of front and back of the side of the health that is arranged in the patient and patient's health substantially.

The same with the embodiment of Figure 1A-D, theelectrode system 100 of Fig. 1 E can comprise each thecontrol unit 30 that is electrically coupled to a plurality of ECG sensing electrodes 10 by correspondinginsulated conductor 15, but can alternatively use wireless ECG sensingelectrode.Control unit 30 for example can comprise the signal acquisition circuit in greater detail about Fig. 2 A-C, 3,9,10 and 11, and control unit also can comprise controller, described controller not only can be monitored the ECG signal from the patient, and can analyze those ECG signals and the patient is started electric shock therapy, if such treatment is given theratification.Control unit 30 can be incorporated among theclothes 20c, is attached toshroud 110, is received in the leather sheath (not shown) or is attached to clip so that it can easily be dressed by the patient, and perhaps controlunit 30 can be carried by the patient with any other suitable way.

The same with previous described embodiment,electrode system 100 comprises that also at least one drives ground electrode 12.As shown in Fig. 1 E, at least one embodiment, at least one drives ground electrode and comprises that threedrive ground electrode 12a, 12b and 12c.Can use to driveground electrode 12a-c with the impact of noise decrease and/or detect the ECG sensing electrode in the mode described in the patent of ' 669 and whether come off.In one embodiment of the invention, drivingground electrode 12a-c also can be as therapeutic electrode to be transported to defibrillation shock patient's health, if such treatment is given the ratification.In this embodiment,electrode 12a and 12b are electrically coupled together and are used as the first therapeutic electrode, andelectrode 12c is as the second therapeutic electrode.The use of two therapeutic electrodes allows biphasic shock is transported to patient's health, so that first in two therapeutic electrodes carried the first-phase of biphasic shock, another therapeutic electrode is as refurn electrode, and another therapeutic electrode is carried the second-phase of biphasic shock, and the first therapeutic electrode is as refurn electrode.Should understand in certain embodiments, can use the defibrillation pulse of the energy of monophasic shocks or other type.

Fig. 1 F shows the electrode system according to another embodiment of the invention 100 that comprises a plurality of ECG sensing electrodes 10.Than the embodiment that describes about Figure 1A-E, be different from attached or be incorporated among clothes 20a, 20b or the 20c, a plurality of ECG sensing electrodes 10 and at least one drive ground electrode 12 each directly be attached to patient's health.Identical with previous described embodiment, each of a plurality of ECG sensing electrodes 10 does not show wherein whole by corresponding covered wire 15(in order to be easy to diagram) be electrically coupled to control unit 30, and electrode system 100 comprises that at least one that be electrically coupled to control unit 30 by insulated conductor 18 drives ground electrode 12.According to aspects of the present invention, control unit 30 can comprise and can be chosen in signal level, noise among a plurality of ECG sensing electrodes 10 that phase place discriminating or any other standard aspect provide the signal acquisition circuit of those electrode pairs of best ECG signal.The same with the previous described embodiment of Figure 1A-E, a plurality of ECG sensing electrodes 10 can be disposed with relative substantially electrode pair (for example, ECG sensing electrode 10a, 10b) around patient's health, perhaps center on simply patient's trunk interval.Although not shown in Fig. 1 F, a plurality of ECG sensing electrodes 10 will typically comprise the ECG sensing electrode of the side of the trunk that is positioned at the patient and patient's front and back.Should understand in being incorporated into clothes 20a-20c those, the embodiment of Figure 1A-E can additionally comprise one or more ECG sensing electrodes (or driving ground electrode) of the health that directly is attached to the patient.

Fig. 1 G shows the plane graph of the electrode system 100 of Figure 1A-1E.As shown in the figure, a plurality of ECG sensing electrodes 10 are arranged in around the different axial locations of patient's health, but they do not need to be deployed in the single plane.In fact, at least one embodiment, a plurality of ECG sensing electrodes all are not positioned in the single plane jointly so that can select electrode pair corresponding to Different Plane.In addition, although a plurality of ECG sensing electrode 10 is shown as disposing with the electrode pair (for example, electrode 10a and 10b, electrode 10c and 10d) that diameter is relative substantially, should understand really not so restriction the present invention.In the embodiment shown in Fig. 1 G, a plurality of ECG sensing electrodes 10 comprise 16 ECG sensing electrodes, spaced apart about 22.5 ° of each ECG sensing electrode and adjacent ECG sensing electrode.In another embodiment, a plurality of ECG sensing electrodes 10 comprise 12 sensing electrodes, spaced apart about 30 ° of each ECG sensing electrode and adjacent ECG sensing electrode, and in another embodiment, a plurality of ECG sensing electrodes comprise spaced apart 18 about 20 ° sensing electrodes.Should understand to provide the sensing electrode of ECG more or less, for example few to three, and in the ECG sensing electrode some or all can be positioned at outside the horizontal plane that the heart with the patient intersects.

Advantageously, the use of a plurality of electrodes allows to select the difference pairing of ECG sensing electrode, and wherein this is chosen in the ECG signal that signal level, vulnerability to jamming, phase contrast, cardiac arrhythmia detection specificity or any other standard aspect provide better or more expect.For example, ECG sensing electrode 10a can match with ECG sensing electrode 10k or 10j, rather than match with ECG sensing electrode 10b, wherein such pairing causes better ECG signal level, better vulnerability to jamming or maximum phase discriminating, and perhaps wherein definite ECG sensing electrode 10b has come off or be bad with patient's Body contact.Difference pairing with the poor ECG sensing electrode of similar phase contrast or expression out of phase can be selected and be compared to each other.For example, spaced apart about 180 ° ECG sensing electrode 10g and 10h can match and the ECG signal with from also spaced apart about 180 ° of ECG sensing electrode 10c and 10d() compare, perhaps alternatively, ECG sensing electrode 10g and 10h can match and ECG signal and comparing in order to screen out noise or derive additional information from spaced apart about 90 ° ECG sensing electrode 10b and 10d.All be not arranged in the situation of single plane at a plurality of ECG sensing electrodes 10, the pairing that can select the ECG sensing electrode is with corresponding to Different Plane.The difference pairing that should understand the ECG sensing electrode does not need separately.For example, ECG sensing electrode 10a can with ECG sensing electrode 10b pairing and ECG signal with from ECG sensing electrode 10a and 10c's and/or comparing from ECG sensing electrode 10a and 10d.

Fig. 2 A shows and can be used for embodiments of the invention to be chosen in signal to noise ratio among a plurality of ECG sensing electrodes, phase place is differentiated or any other standard aspect provides the ECG signal of expectation and those ECG signals are offered the signal acquisition circuit of pairing that circuit downstream carries out those electrodes of further Signal Regulation, processing, analysis and/or monitoring.Advantageously, the signal acquisition circuit shown in Fig. 2A 200 can be as about the described analog digital conversion of arrhythmia detection system of Fig. 2 a-2c of ' 669 patent and the front end of Signal Regulation piece 14.

As shown in the figure,signal acquisition circuit 200 comprises theselection circuit 210 that is electrically coupled to differential circuit 220.Each signal from a plurality ofECG sensing electrode 10a-10p offers thecorresponding input 212 of selecting circuit 210.Come the one or more signal in the self-drivenground electrode 12 also can offer theinput 212 of selectingcircuit 210, so that signal can driveground electrode 12 transmission, and this signal with whether break away from the perhaps identification noise problem relevant with specific ECG sensing electrode to identify specific ECG sensing electrode in each signal comparisons that receives of a plurality of ECG sensing electrodes.Select circuit 210 to have a plurality ofoutputs 216 of thecorresponding input 222 that is electrically coupled to difference channel 220.In operation,select circuit 210 to operate in the mode that is similar to many output multi-channels multiplexer, and comprise that a plurality ofcontrol inputs 214 are to select from different ECG sensing electrodes and/or to drive the signal of ground electrode and those selected signals are offered theinput 222 of difference channel 220.Should understand except single choice is selected circuit, the single output multi-channel multiplexer of a plurality of routines can be used for realizing identical functional.

Difference channel 220 comprise thedifferential instrument amplifier 220a of a plurality of simulations, 220b ... 220n, receiving by difference pairing and/or the corresponding ECG sensing electrode of ECG sensing electrode and the different signals that provide that match of ground electrode are provided, and provide the correspondingdifferential output signal 226 corresponding to the difference between them.Offerrespective amplifier 220a, 220b ... in the situation of the signal of 220n corresponding to the signal that is provided by different ECG sensing electrodes, provide the differential ECG signal.Before further being analyzed and/or monitored by Monitoring on arrhythmia and/or therapy system (for example wearable defibrillator), then this differential simulation ECG signal can digitally be changed and be regulated by analog digital conversion and the Signal Regulation piece of the arrhythmia detection system of for example describing about Fig. 2 a-2c of ' 669 patent.

Fig. 2 B shows and can be used for embodiments of the invention to be chosen in signal to noise ratio among a plurality of ECG sensing electrodes, phase place is differentiated or any other standard aspect provides the ECG signal of expectation and those ECG signals are offered the alternative signal Acquisition Circuit of pairing that circuit downstream carries out those electrodes of further Signal Regulation, processing, analysis and/or monitoring.The signal acquisition circuit 200a that has just described about Fig. 2 A above signal acquisition circuit 200b roughly is similar to, and therefore only in Fig. 2 B, shownselection circuit 210, and the other parts of not shown circuit 200a, for example differential circuit 220.Yet except any pairing that can select the ECG sensing electrode, any one among the other a plurality ofECG sensing electrode 10a-10p of permission of signal acquisition circuit 200b is as driving ground electrode.

Technical staff in the signal processing field is well-known, drives ground electrode through being usually used in eliminating noise many or that all sensors (for exampleECG sensing electrode 10a-10p) may have.The noise signal that is present on some or all in the sensor (for example ECG sensing electrode) is summed, then anti-phase, and then input drives in the grounded circuit.Be to be attached in patient's the situation of ECG sensing electrode of health at sensor, inversion signal can be driven on patient's the health on one's own initiative, and it is picked up by the ECG sensing electrode on patient's health, effectively eliminates usually the noise that is detected.

Yet, in wearable medical treatment device (for example described wearable medical treatment device about Figure 1A-F), may exist for the drivingground electrode 12 that will drive ground signalling and be transferred to patient's health may come off, lose and the contacting or the situation of irregular working just of patient's health.In fact, even in the situation of and normal operation good in the Body contact that drivesground electrode 12 and patient, drive ground electrode and may just be positioned at the suboptimum position.In the situation of any one existence in these situations, one or more can being used as among a plurality ofECG sensing electrode 10a-10p drives ground electrode.With reference now to Fig. 2 B, this aspect of the present invention is described in more detail.

As shown in Fig. 2 B, a plurality of signal pins 230 can be provided, each corresponding signal foot 230a-230p is electrically coupled to and drives the grounded circuit (not shown).A plurality of switches 232 are provided, and each respective switch 232a-p electric coupling is between the corresponding input 212a-p of corresponding ECG sensing electrode 10a-p and selection circuit 210.Each switch 232a-p can be in two positions.In primary importance, switch 232 is electrically coupled to the corresponding ECG sensing electrode of electricity 10a-p the corresponding input 212a-p that selects circuit.In the second position, switch 232 is electrically coupled to corresponding signal foot 230a-p with respective electrode 10a-p, and described signal pins is electrically coupled to the driving grounded circuit.For example, as shown in Fig. 2 B, switch 232a is in certain position so that signal pins 230a is electrically coupled to ECG sensing electrode 10a, and switch 232b, 232c ... each of 232p is in certain position so that ECG sensing electrode 10b-10p correspondingly is electrically coupled to the corresponding input 212b-212p that selects circuit 210.In this configuration, provide in the situation of the better signal on other sensing electrode in a plurality of ECG sensing electrodes in this use, another drive ground electrode and patient's health lost contact or the situation of loose contact under, or owing to any other reason, ECG sensing electrode 10a can be as driving ground electrode.

Thereby Fig. 2 C show can be used for embodiments of the invention with above being similar to about Fig. 2 A and the described mode of 2B select the ECG sensing electrode pairing and with allow a plurality of ECG sensing electrodes about the described mode of Fig. 2 B above being similar to any one as another alternative signal Acquisition Circuit that drives ground electrode.The signal acquisition circuit 200b that signal acquisition circuit 200c has just described above roughly being similar to, and therefore difference is only described.

With the same among the signal acquisition circuit 200b, a plurality of signal pins 230 are provided, each corresponding signal foot 230a-230p is electrically coupled to and drives the grounded circuit (not shown).A plurality of switches 232 also are provided.Each respective switch 232a-p of a plurality of switches 232 is electrically coupled to the corresponding signal foot 230a-p of a plurality of signal pins 230, and the corresponding signal foot is electrically coupled to again and drives the grounded circuit (not shown).Each switch 232a-p can be in two positions (open and close).At open position, the driving ground signalling on the corresponding signal foot 230a-p is open circuit, and in make position, switch 232 is electrically coupled to corresponding signal foot 230a-p with corresponding ECG sensing electrode 10a-p.For example, as shown in Fig. 2 C, each of switch 232a and switch 232c-232p is shown in an open position, and switch 232b is in the close position, so that signal pins 230b is electrically coupled to ECG sensing electrode 10b.The fact that this embodiment relies on is to select circuit 210 usually will have than high input impedance, so that input 212 each can remain connected to ECG sensing electrode 10, this ECG sensing electrode is electrically coupled to the driving grounded circuit simultaneously, and reason is to drive grounded circuit will typically have than low output impedance.In this configuration, provide in the situation of the better signal on other sensing electrode in a plurality of ECG sensing electrodes in this use, another drive ground electrode and patient's health lost contact or the situation of loose contact under, or owing to any other reason, ECG sensing electrode 10b can be as driving ground electrode.

Should understand in the embodiment of above-mentioned Fig. 2 B and 2C, can provide more than one and drive grounded circuit.For example,ECG sensing electrode 10a can be with acting onECG sensing electrode 10c, 10d, 10o, 10n, 10e, 10h, 10i and 10l(referring to Fig. 1 G) the driving ground electrode, andECG sensing electrode 10b can be with the driving ground electrode that acts onECG sensing electrode 10m, 10p, 10g, 10f, 10k and 10j.

Fig. 3 shows and can be used for and drive the different pairing acquired signal of ground electrode and those signals being offered the signal acquisition circuit according to another embodiment of the invention of circuit downstream (for example the A/D of Monitoring on arrhythmia and/or therapy system changes and Signal Regulation piece 330) from the difference pairing of ECG sensing electrode or from the ECG sensing electrode.As shown in Figure 3, signal acquisition circuit 300 comprise the differential instrument amplifier 320a-320n of a plurality of simulations, the 321a-321n-1 that all are configured to receive from the signal of the difference pairing of ECG sensing electrode ... 329a.For example, the first grouping of amplifier 320a-320n can be configured to correspondingly match ECG sensing electrode 10b-10p(Fig. 1 G) each and ECG sensing electrode 10a, the second grouping of amplifier 321a-321n-1 can be configured to correspondingly to match each and the ECG sensing electrode 10b of ECG sensing electrode 10c-10p, etc.Although show, each grouping of amplifier also can be relatively from the signal of corresponding ECG sensing electrode and each of driving ground electrode or a plurality of driving ground electrodes.Compare with the signal acquisition circuit 200 of Fig. 2 A-C, directly offer the input of respective amplifier from each independent signal of the difference of ECG sensing electrode pairing.Thereby this embodiment can avoid by selecting circuit 210 to be positioned at the noise or signal degeneration that differential circuit 220 causes before.Such selection circuit can change into and be located at analog digital conversion and Signal Regulation piece (analog digital conversion and the Signal Regulation piece 14 for example described about Fig. 2 a-2c of ' 669 patent) afterwards.For example, as shown in Figure 3, the differential output signal of simulation that is provided by each respective amplifier 320a-320n, 321a-321n-1,329a can offer digitized and regulate the A/D conversion of the differential output signal of simulation and the corresponding input 332 of Signal Regulation piece 330.Then the digitized that provides at A/D conversion and Signal Regulation piece 330 and conditioning signal can offer to be similar to the corresponding input 342 of the output select circuit 340 that the mode of many output multi-channels multiplexer operates.Response offers the control signal of the control inputs 344 of selecting circuit 340, selects circuit to select those digitizeds and conditioning signal to select the corresponding output 346 of circuit to monitor and/or analyze to offer among a plurality of digitizeds and conditioning signal.

According to aspects of the present invention, can select ECG sensing electrode 10 difference pairing each and the signal of analyzing them be identified in signal to noise ratio, phase place is differentiated or any other standard aspect provides those pairings of ECG sensing electrode of the ECG signal of expectation.Then can select to provide highest signal to noise ratio, particular phases differentiate those pairings of the ECG sensing electrode that maximum phase is differentiated or corresponding to those pairings of the electrode of specific plane those signals are offered heart monitor or for example offer the arrhythmia detection system shown in Fig. 2 a-c of ' 669 patent, provide quality signal (aspect high s/n ratio and maximum phase discriminating) if determine the pairing ofECG sensing electrode 10a and 10j and 10c and 10d, but the pairing ofECG sensing electrode 10a and 10b is not like this, then from the signal ofECG sensing electrode 10j will withECG sensing electrode 10a pairing and can be with respect to from the signal analysis ofECG sensing electrode 10c and the 10d signal from these ECG sensing electrodes.

Should understand embodiments of the invention provides and can select to provide quality signal, given reference phase difference among a plurality of electrodes or maximum phase is differentiated or cardiac monitoring system and/or cardiac monitoring and the arrhythmia detection system of those pairings of the electrode of any other standard.Have the ability of selecting the ECG sensing electrode, the analyzer of cardiac monitoring and arrhythmia detection system for example can be suitable for providing best orthogonal view and can provide than list or the more heart information of dual pathways sensing system.Analyzer can select to represent the template of different view planes of a plurality of templates at the out of phase angle between the ECG sensing electrode wire or expression patient's heart.Each electrode channel can self correlation (with self relatively) or cross-correlation (with other passage relatively) in order to screen out noise and derive additional information.

If total electrode system time afterwards moves, for example when electrode was configured to wearable shroud or clothes system a part of, embodiments of the invention also can return best axial location.Because the configuration of this multi-electrode can select to have the electrode of signal best in quality, therefore since the quantity of the alarm that ECG noise and coming off causes can reduce.The subsidiary effect of another of cleaner ECG signal is reducing of false detection.By checking a plurality of electrodes, and find great majority just in the identical situation of sensing, embodiments of the invention can increase the confidence level of detection algorithm.In addition, when dressing electrode shroud or clothes, electrode can move to slightly different positions, causes the variation of ECG signal.Use multi-electrode configuration, detection system can scan a plurality of paths and select quality signal.In addition, by provide redundant for sensing system, this multi-electrode disposes and helps improve the total system reliability.Mistake in one or more passages can allow that reason is to also have other service aisle.About Fig. 4-8 these and other aspect of the present invention is described now.

Fig. 4 illustrates in function can be by the control unit of portable medical device according to the present invention (for example heart monitor or wearable defibrillator) use, for example control unit shown in Figure 1A-F 30.As shown in the figure,control unit 30 comprises at least oneprocessor 410,battery 420,data storage 412,sensor interface 414,treatment interfacing conveyor 416 and user interface 418.Battery 420 can be the rechargeable three battery 2200mAh lithium ion battery groups that electric power is provided for other devicefeature.Data storage 412,sensor interface 414,treatment interfacing conveyor 416 anduser interface 418 are coupled at least one processor 410.Data storage 412 comprises computer-readable and the writable data storage medium that is configured to store nonvolatile instruction and other data, and can comprise non-volatile memory medium (for example CD or disk, ROM or flash memory) and volatile memory (for example RAM).Instruction can comprise and can carry out hereinafter executable program or other code of described any function by at least oneprocessor 410.

Treatment interfacing conveyor 416 will be such asdefibrillation therapy electrode 12a-c(Fig. 1 E) one or more treatment conveyer devices be coupled at least one processor 410.Only be used at control unit can omittingtreatment interface 416 and related defibrillation therapy electrode in monitoring patient's the situation ofheart.User interface 418 comprises the combination of the hardware and software parts thatpermission control unit 30 is communicated by letter with external entity (for example user).These parts are configured to receive the information from movable (for example physical motion, oral intonation or thinking process).In addition, the parts ofuser interface 418 can be for example for example in the mode described in No. the 6th, 681,003, the United States Patent (USP) that is incorporated in by reference herein information is offered external entity.The example that can be used for the parts in theuser interface 418 comprises keyboard, mouse apparatus, tracking ball, mike, electrode, touch screen, printing equipment, display screen and speaker.

Sensor interface 414 is coupled to a plurality of biosensors with at least oneprocessor 410, for example a plurality of ECG sensing electrodes 10.In certain embodiments,sensor interface 414 also can be coupled to other biosensor with at least oneprocessor 410, such as activity sensor, pulse oximetry sensor, temperature sensor, respiration rate sensor, transthoracic impedance sensor, pressure transducer, sonic transduceretc.Sensor interface 414 can comprise signal acquisition circuit, for example top about Fig. 2 A-C and 3 describedsignal acquisition circuits 200 and 300, or the followingsignal acquisition circuit 900,1000 and 110 that further describes about Fig. 9-11, thereby be chosen in signal to noise ratio among a plurality of ECG sensing electrodes and/or other biosensor, phase place is differentiated or any other standard aspect provides those of desired signal.

Although it is not shown in Figure 4, but control unit 30 can comprise optional feature and/or interface, communications network interface (wired and/or wireless) for example, and at least one processor 410 for example can comprise on July 9th, 2010 to be submitted to, name is called " system and method (SYSTEM AND METHOD FOR CONSERVING POWER IN A MEDICAL DEVICE) that is used for the electric power of saving medical treatment device ", serial number is 12/833,096 and intactly is incorporated in by reference the power-saving processor described in herein the common pending application (be called as hereinafter " ' 096 application ") and arranges.For example, described in ' 096 application, at least one processor 410 can comprise and is coupled to application specific processor (Freescale for example^TMDSP56311 digital signal processor (DSP)) general processor (for example

Processor).General processor can be configured to carry out the Nonvital Function that does not need real-time processing, for example dock with communications network interface and user interface, and application specific processor is configured to carry out the key function that needs are processed in real time, for example the sampling and analyzing of ECG information, charge the capacitor to generation and/or the conveying of specific voltage and treatment defibrillation pulse.Should understand in certain embodiments the functional at the scene programmable gate array (FPGA) of at least one processor, one or more PLD (PLDs), complicated PLD(CPLD) or the middle realization of custom application-specific integrated-circuit (ASIC).

Fig. 5-8 according to embodiments of the invention show can by at least oneprocessor 410 ofcontrol unit 30 carry out to improve cardiomotility monitoring and analysis, improve the detection of heart abnormality and reduce false detection and a plurality of various process of the quantity of the alarm that comes off.

Fig. 5 shows according to one embodiment of present invention and can carry out those the selection course that the most high-quality ECG signal is provided to be chosen in signal to noise ratio and maximum phase discriminating aspect among a plurality of ECG sensing electrodes 10 by at least oneprocessor 410 of controlunit 30.In action 510, at least oneprocessor 410 selects a pair of ECG sensing electrode to monitor.As discussed previously, this can send to suitable control signal by at least one processor selects circuit 210,340 to carry out.

Inaction 520, at least one processor analysis is from ECG signal and the record identification selecteed ECG sensing electrode right information and indication tolerance from the quality of its ECG signal that provide of selecteed ECG sensing electrode to obtaining.Although a plurality of various criterions can be used for the quality of identification ECG signal, in one embodiment, have the quality metrics that those ECG signals of highest signal to noise ratio and maximum phase discriminating are endowed and be higher than those pairings that are not such.

Inaction 530, at least one processor determine whether to select with the analysing ECG sensing electrode may match each.In the situation about might match of determining to have selected with the analysing ECG sensing electrode, this process enters moves 540.Alternatively, determine to have selected with being less than of analysing ECG sensing electrode all situation about may match under, thisprocess return action 510 is wherein selected next sensor pairing.Then for eachexecution action 510 to 530 that may match of ECG sensing electrode.

Inaction 540, at least one processor selects to have those pairings of the ECG sensing electrode of high-quality tolerance among a plurality of different pairings of ECG sensing electrode.The quantity that should understand the difference pairing of the ECG sensing electrode of selecting inaction 540 will depend on the A at differential circuit 220(Fig. 2)output 226 or the quantity of the different passages that provide in theoutput 346 of theselection circuit 340 of Fig. 3.Generally speaking, inaction 540, will select minimum two passages, and in most implementations, will select at least four different passages.The quantity of the passage that provides in certain embodiments, can be corresponding to each unique pairing of electrode.

Inaction 550, at least one processor monitoring and analyze the ECG signal that the selected pairing by the ECG sensing electrode provides.Monitoring and analyze by selected ECG sensor and can continue the action (that is, action 550) of the ECG signal that provides until stopped by removal and/or the power down of wearable medical treatment device.

According to one embodiment of present invention, when powering onelectrode system 100, can carry out about the described selection course of Fig. 5 to compensate any may relocate of a plurality of electrodes 10 on patient's health.Therefore, for example, take a shower when theclothes 20a-20c that compriseselectrode system 100 removes to allow the patient from patient's health, in order to serve or owing to any other reason and when then turning back to position on patient's the health, the location of some or all in the ECG sensing electrode may change from their previous position.By the selection course of execution graph 5, electrode system can select to provide those pairings of the ECG sensing electrode of the most high-quality ECG signal, no matter those pairings of ECG electrode select with previous those are identical or different.In some implementation, the initial pairing of ECG sensing electrode can be based on previous those that select in action 540.For example, respond the patient was just being removed and turning back to the clothes that compriseselectrode system 100 from patient's health health, electrode system initially can be based on the pairing of those selections ECG sensing electrode of selecting inaction 540 before removing clothes.Then this initial selected can be confirmed by the selection course of execution graph 5 again.

Should understand and with periodic intervals (for example per half an hour) or to respond the violent body movement of another sensor (for example activity sensor) indication and carry out again about the described selection course of Fig. 5 to guarantee to select the best pairing of ECG sensing electrode.By termly or the detected body movement of response carry out again selection course, embodiments of the invention can guarantee to provide those pairings of the ECG sensing electrode of the most high-quality ECG to be identified and be used for monitoring and analyze.

Although the selection course of Fig. 5 is described to be chosen in those ECG sensing electrodes pair that signal to noise ratio and maximum phase discriminating aspect provide the most high-quality ECG signal, should understands and to use other standard.For example, can make amendment to select before being included inaction 510 action of expectation template about the described process of Fig. 5.The expectation template for example can reflect the out of phase angle between the ECG sensing electrode of expecting monitoring.Theaction 510 and 520 of selecting and analyzing different ECG sensing electrodes pairings therefore can be among a plurality of ECG sensing electrodes selects to provide those ECG sensing electrodes pair of highest signal to noise ratio among those pairings at (one or more) expectation phase angle of satisfying template.Other standard that can in template, reflect except the phase angle should be understood, and a plurality of templates can be provided and/or select.For example, template can be corresponding to the different pairings of the ECG sensing electrode of the Different Plane of intersecting from patient's heart, and another template can be corresponding to the differences pairing that all jointly is positioned at the ECG sensing electrode in the same level.

Fig. 6 shows according to aspects of the present invention can be by control unit 30(Fig. 4) at least oneprocessor 410 carry out to improve the quality of the monitoring of ECG signal and analysis and/or the quantity of the alarm that reduces to come off noise/testing process comes off.At least one processor monitoring and analysis are from the selected ECG signal of the difference pairing of ECG sensing electrode in action 610.The pairing of monitored ECG sensing electrode with analyzing can be before based on for example selected about the described selection course of Fig. 5 inaction 610.In action 620, whether at least one processor is about there being coming off or determining with at least part of contact loss of patient's health of noise or the selected pairing of the no ECG of having sensing electrode in the ECG signal of the selected pairing of ECG sensing electrode.Any selected pairing of determining the ECG sensing electrode inaction 620 does not have obvious noise or the signal that reduces or lacks in the situation of signal at least oneprocessor return action 610 and the selected ECG signal of continuation monitoring.Alternatively, defining from one obvious noise or the signal that reduces in the selected pairing of ECG sensing electrode or lacking in the situation of signal, this process entersaction 630.

At least oneprocessor 410 selects the new pairing of ECG sensing electrode to replace the pairing of the ECG signal that wherein detects the noise of increase or reduce in action 630.Can be to be similar to themode execution action 630 about the described selection course of Fig. 5.Theaction 630 in, can revalue the ECG sensing electrode may match each to select those pairings of ECG electrode to be monitored.Alternatively, those selected pairings of the ECG sensing electrode that does not wherein detect noise or come off can keep as selected pairing, and estimate residue ECG sensing electrode with identification and the pairing of selecting the ECG sensing electrode to replace the pairing that wherein detects noise or come off.The new pairing of response ECG sensing electrode or the selection of a plurality of new pairings, this process turns back to monitoring and analysing ECG signal inaction 610.

Although in Fig. 6, do not show, respond the noise in the selected pairing of ECG sensing electrode or the detection that comes off, at least oneprocessor 410 can carry out additional testing to selected pairing.For example, at least one processor can match selected right each ECG sensing electrode and drive ground electrode and be selected in the right ECG sensing electrode which and may have noise problem or may lose at least in part and the contacting of patient's health to identify.The user (or other people) that at least oneprocessor 410 also can send a message to the portable medical device viauser interface 418 may have noise problem with one or more in the ECG sensing electrode of notifying the selected pairing of user or may lose at least in part and the contacting of patient's health, and can require the user to relocate the ECG sensing electrode of selected pairing.

Fig. 7 shows monitoring and the analysis routines that can be carried out by at least oneprocessor 410 ofcontrol unit 30 quantity improving the detection of cardiac arrhythmia and reduce false detection.At least one processor monitoring and analysis are from the selected ECG signal of the difference pairing of ECG sensing electrode in action 710.The pairing of monitored ECG sensing electrode with analyzing can be before based on for example selected about the described selection course of Fig. 5 inaction 710.In action 720, determine about whether having detected cardiacarrhythmia.In action 720, determine also not detect in the situation of cardiac arrhythmia (ventricular tachycardia or ventricular fibrillation) thisprocess return action 710 and continuation monitoring and the selected ECG signal of analysis.Alternatively, inaction 720, determine to have detected in the situation of cardiac arrhythmia, at least one processor entersaction 730, and wherein at least one processor is set labelling or the indicator that identification has detected cardiac arrhythmia, and at least one processor entersaction 740.

Inaction 740, whether at least oneprocessor 410 selects the different or additional pairing of ECG sensing electrodes to monitor to identify to be determined arrhythmia also to be present in the ECG signal from other pairing of ECG sensing electrode.Additional or the different pairings of ECG sensing electrode can be based on before about the described selection course of Fig. 5.For example, the additional or different pairings of the ECG sensing electrode of selecting inaction 740 can provide one or more in those pairings of time high signal quality level, rather than in theaction 540 of Fig. 5, selectthose.In action 750, at least one processor continues monitoring and analyzes to be selected the ECG signal, comprises coming additional or different those that match of the ECG sensing electrode of selecting in thecomfortable action 740.

In action 760, at least one processor 410 determines whether to have detected cardiac arrhythmia again based on the ECG signal of monitoring in action 750.Also do not detect in the situation of cardiac arrhythmia in different or additional pairing determining, at least one processor is return action 750 and continue the selected ECG signal of monitoring simply.Yet, in action 760, to determine to have detected in the situation of cardiac arrhythmia (ventricular tachycardia or ventricular fibrillation), at least one processor can enter action 770.In action 770, response detects cardiac arrhythmia and still exists or also be present in the additional or different pairings of being selected of ECG sensing electrode, and at least one processor is increased in the indicator of setting in the action 730 or the confidence level of labelling.Although in Fig. 7, do not show, but the response confidence level is on certain threshold value, and cardiac arrhythmia is the type that is fit to carry out the cardiac arrhythmia of defibrillation therapy, and at least one processor 410 can be carried out the one or more instructions that cause via treatment interfacing conveyor 416 defibrillation being put on patient's health.According to this aspect of the present invention, the cardiac arrhythmia that detects by response checks other pairing of ECG sensing electrode, and the detection specificity of cardiac arrhythmia can increase and the quantity of the false detection of cardiac dysfunctions can reduce.

Fig. 8 shows monitoring according to another embodiment of the invention and the analysis routines that can be carried out to improve by at least oneprocessor 410 ofcontrol unit 30 monitoring and the analysis of cardiomotility.At least one processor monitoring and analysis are from the selected ECG signal of the difference pairing of ECG sensing electrode in action 810.The pairing of monitored ECG sensing electrode with analyzing can be before based on for example selected about the described selection course of Fig. 5 inaction 810, and perhaps they can be owing to other reason is selected.For example, the pairing of ECG electrode can not provide all ECG sensors the most high-quality right ECG signal, but can be corresponding to a specific plane and a plurality of plane, perhaps corresponding to the ad-hoc location with respect to heart.

In action 820, at least one processor 410 monitorings and analyze the ECG signal that the selected pairing by the ECG sensing electrode provides.In action 830, monitor about the new pairing of whether selecting the ECG sensing electrode and determine.About the new pairing of whether selecting the ECG sensing electrode determine can be based on a plurality of various criterions, comprise can be once period (such as relaxing period and systole), ECG sensing electrode of type, cardiac cycle of information of quantity, search of the monitored and passage analyzed with respect to position and/or the depolarization of heart or polarize the phase again (such as the PQRST waveform indication by the ECG signal) etc. of heart.For example, can monitor simultaneously three different passages and a plurality of ECG sensing electrode 10 comprises in the situation of 12 ECG sensing electrodes at control unit 30, three of the ECG sensing electrode different pairings (comprising six different ECG sensing electrodes) are can be during the first period monitored and analyze, and can be during the second follow-up period monitored and analyze in three pairings of residue of not monitored during the first period and the ECG sensing electrode analyzed.Alternatively, can monitor simultaneously three different passages and a plurality of ECG sensing electrode 10 comprises in the situation of 16 ECG sensing electrodes (as shown in Fig. 1 G) at control unit, comprise that the ECG sensing electrode is to 10o-10p, 10c-10d, three different pairings of the ECG sensing electrode of 10m-10n are can be during the first period monitored and analyze, comprise that the ECG sensing electrode is to 10g-10h, three different pairings of the ECG sensing electrode of 10k-10l and 10b-10a can be monitored during the second period, and comprise that the ECG sensing electrode is to 10j-10i, three different pairings of the ECG sensing electrode of 10f-10e and 10o-10p can monitored and analysis during the first period.In this mode, the selected pairing of ECG electrode can be scanned around the circumference of heart.Should understand quantity at the passage that can be monitored simultaneously by control unit 30 is enough to monitor in the situation of all unique pairings of all pairings of ECG sensing electrode or ECG sensing electrode, then can monitor simultaneously all such pairings.

Therefore, inaction 830, in the situation of new or different pairings with monitored and analysis of definite ECG sensing electrode, monitoring and analysis routines returnaction 810 are wherein selected those new or different pairings of (action 810) and monitoring and analysis (action 820) ECG sensing electrode.Alternatively, the new or different pairings of definite ECG sensing electrode are not in the situation of expectation inaction 830, the pairing ofroutine return action 820 and the previous ECG sensing electrode of selecting of continuation monitoring.

Fig. 9 shows and can be used for embodiments of the invention to be chosen in signal to noise ratio among a plurality of ECG sensing electrodes, phase place is differentiated or any other standard aspect provides those pairings of the electrode of expecting the ECG signal and those ECG signals are offered the alternative signal Acquisition Circuit that circuit downstream carries out further Signal Regulation, processing, analysis and/or monitoring.With before compared with 3 described embodiment about Fig. 2 A-C, signal acquisition circuit 900 does not comprise any differential amplifier, but changes the differential ECG signal that generates in the software of being carried out by processor (for example before described at least oneprocessor 410 about Fig. 4) corresponding to the selected pairing of ECG sensing electrode into.

As shown in the figure, signal acquisition circuit 900 comprises analog multiplexer 910 and modulus (A/D) transducer 920.Offer the corresponding input of a plurality of inputs 912 of intending multiplexer 910 from each the signal of a plurality of ECG sensing electrode 10a-10p.Intend the output 916 that multiplexer has the input 922 that is electrically coupled to A/D converter 920.Intend multiplexer 910 and comprise that from a plurality of signals that corresponding ECG sensing electrode 10a-10p receives which a plurality of control inputs 914 to select offer the input 922 of A/D converter 920.A/D converter 920 receives from selecteed one the selected signal in a plurality of ECG sensing electrodes and should to simulate the ECG conversion of signals be digital signal.In order to guarantee that A/D converter 920 can be 24 A/D converters for the enough resolution of the processing of the digitized signal of being carried out by at least one processor 410, has the still less A/D converter of position but can use.Generally speaking, the sample rate of A/D converter 920 should be the ECG signal the expectation sample rate at least N doubly, wherein N is the quantity of the monitored ECG sensing electrode of expectation.For example, monitor in the situation of the ECG signal that is provided by three right each of ECG sensing electrode with the sample rate of 400Hz in expectation, A/D converter 920 should have the sample rate above 2.4KHz.Should understand certainly and can use higher sample rate.

Although in Fig. 9, do not show, from each of the signal of corresponding ECG sensing electrode 10-10p before the corresponding input of analog multiplexer 910 is received, at first can be cushioned, filtering and/or amplification.For example, each signal of the corresponding reception from a plurality of ECG sensing electrode 10a-p can offer the input of high impedance buffer so that analog multiplexer and A/D converter do not make corresponding ECG sensing electrode overload.The output of respective buffer can be carried out low-pass filtering (namely, sawtooth disappears) be lower than the Nyquist frequency of A/D converter 920 with any frequency component that guarantees signal, and offer at the signal through filtering before the corresponding input of analog multiplexer 910 this signal offer low noise and low to middle gain amplifier with amplifying signal.It will be appreciated by those of skill in the art that, buffering, filtering and/or amplification can be carried out in a plurality of and different stages (for example following filtering stage and one or more amplification stage after the high impedance buffer stage) from the combination of the signal of each reception of a plurality of ECG sensing electrodes, and perhaps some in these stages (for example buffering and amplification stage) can be carried out (for example having low high impedance low-noise amplifier to middle gain) in single phase.In certain embodiments, amplification stage can be able to programme by at least one processor 410.

According to an embodiment, analog multiplexer 910 can be the conventional simulation multiplexer that can obtain from company (for example Analog Devices company of Massachusetts Nuo Wude city (Norwood)), wherein is chosen in the signal that the corresponding input of multiplexer receives which in the control signal that the control inputs of analog multiplexer receives and offers output.A/D converter 910 is converted to received signals digital signal and will offers at least one processor 410 through the digital signal of conversion.At least one processor is configured to control each of signal that multiplexer 910 and/or A/D converter 920 receive from corresponding ECG sensing electrode in the different periods with sampling and conversion and the signal through conversion will be offered at least one processor 410.Depend on that to select among a plurality of ECG sensing electrode 10a-p which paired with each other, at least one processor 410 is got two selected digital signals, anti-phase in them one, and summing signal is digitally carried out with top effectively about functional identical with 3 described differential instrument amplifiers of Fig. 2 A-C.Can carry out the right selection of selected digital signal, anti-phase and summation to any pairing of ECG sensing electrode.Then can process digital summing signal with monitoring patient's ECG signal, detect any arrhythmic heart conditions or both have concurrently.Should understand can to carry out which of pairing and monitoring ECG sensing electrode centering by at least one processor in software right to be similar to the mode shown in Fig. 5.Each of digitized signal can be compared to each other to be used for maximum phase discriminating or given reference phase difference or be used for any other standard.Then can select and those pairings of monitoring and analysing ECG sensing electrode in above-mentioned mode.

According to an alternative embodiment, analog multiplexer 910 can be analog sampling and keep multiplexer, it can be sampled during the first period simultaneously from the signal of each reception of a plurality of ECG sensing electrodes, and then during the follow-up period a plurality of each that are sampled signal is offered A/D converter 920.In this embodiment, at least one processor 410 is configured to control simulation multiplexer 910 and A/D converter 920 with sampling during the first period and keeps from the signal of each reception of a plurality of ECG sensing electrodes, and each or the selected signal that will be sampled signal during the follow-up period offer A/D converter 920 to be converted to digital signal and to offer at least one processor.With the same in above-described embodiment, depend on that to select among a plurality of ECG sensing electrode 10a-p which paired with each other, at least one processor 410 is got two selected digital signals, anti-phase in them one, and summing signal is digitally carried out with top effectively about functional identical with 3 described differential instrument amplifiers of Fig. 2 A-C.Can carry out the right selection of selected digital signal, anti-phase and summation to any pairing of ECG sensing electrode.Then can process digital summing signal with monitoring patient's ECG signal and/or detect any arrhythmic heart conditions.

Figure 10 shows and can be used for embodiments of the invention to be chosen in signal to noise ratio among a plurality of ECG sensing electrodes, phase place is differentiated or any other standard aspect provides those pairings of the electrode of expecting the ECG signal and those ECG signals are offered another alternative signal Acquisition Circuit that circuit downstream carries out further Signal Regulation, processing, analysis and/or monitoring.With before compared with 3 described embodiment about Fig. 2 A-C,signal acquisition circuit 1000 does not comprise any differential amplifier, but changes the differential ECG signal that generates in the software of being carried out by processor (for example before described at least oneprocessor 410 about Fig. 4) corresponding to the selected pairing of ECG sensing electrode into.

As shown in the figure,signal acquisition circuit 1000 comprises a plurality of moduluses (A/D) transducer 1010a-p.Each of a plurality of A/D converter 1010a-p is configured to receive corresponding one signal among a plurality ofECG sensing electrode 10a-p, for example the first A/D converter 1010a receives the signal fromECG sensing electrode 10a, A/D converter 1010b receives the signal fromECG sensing electrode 10b, etc.Each corresponding A/D converter 1010a-p is digital signal with conversion of signals, and in communication link 1020(serial or parallel bus for example) on the digital signal through conversion will be offered at least one processor 410.Although in Figure 10, do not show, but from each of the signal of corresponding ECG sensing electrode 10-10p before the corresponding input of corresponding A/D converter 1010a-p is received, at first can with above being similar to about the described mode of Fig. 9 be cushioned, filtering and/or amplification, so that A/D converter does not make corresponding ECG sensing electrode overload, and guarantee that any frequency component of received signals is lower than the Nyquist frequency of corresponding A/D converter 1010a-p.

In order to guarantee that each of a plurality of A/D converter 1010a-p can be 24 A/D converters for the enough resolution of the processing of being carried out by at least one processor 410, has the still less A/D converter of position but can use.Compare about the described embodiment of Fig. 9 with top, each of a plurality of A/D converter 1010a-p of this embodiment does not need to have the N sample rate doubly of the expectation sample rate that is the ECG signal, wherein N is the quantity of the ECG sensing electrode of expectation monitoring, and reason is each of the signal that receives from corresponding ECG sensing electrode of can sampling concurrently.For example, monitor in the situation of the ECG signal that is provided by three right each of ECG sensing electrode with the sample rate of 400Hz in expectation, each of a plurality of A/D converters can have the sample rate of 400Hz, allows thus the use of lower-cost A/D converter.Certainly, should understand and to use higher sample rate.According to this embodiment, at least one processor 410 control signal can be sent to a plurality of A/D converter 1010a-p each with at roughly the same period sampling corresponding signal, and then will be sampled and send to processor through the digital signal of conversion at follow-up time.Depend on that to select in a plurality of ECG sensing electrodes which paired with each other, at least one processor is got two selected digital signals, anti-phase in them one, and summing signal digitally carry out with top effectively about functional identical with 3 described differential instrument amplifiers of Fig. 2 A-C.Can again carry out the right selection of selected digital signal, anti-phase and summation to any pairing of ECG sensing electrode.Then can process digital summing signal with monitoring patient's ECG signal and/or detect any arrhythmic heart conditions.

Figure 11 shows and can be used for embodiments of the invention to be chosen in signal to noise ratio among a plurality of ECG sensing electrodes, phase place is differentiated or any other standard aspect provides those pairings of the electrode of expecting the ECG signal and those ECG signals are offered another alternative signal Acquisition Circuit that circuit downstream carries out further Signal Regulation, processing, analysis and/or monitoring.This embodiment and top similar part about Fig. 9 and 10 described embodiment are that it does not still comprise any differential amplifier, but change the differential ECG signal that generates in the software of being carried out by processor (for example before described at least oneprocessor 410 about Fig. 4) corresponding to the selected pairing of ECG sensing electrode into.

With top about the same among the described embodiment of Figure 10,signal acquisition circuit 1100 shown in Figure 11 comprises a plurality of moduluses (A/D) transducer 1110a-p again, and wherein each is configured to receive corresponding one signal among a plurality ofECG sensing electrode 10a-p.Although in Figure 11, do not show, but from each of the signal of corresponding ECG sensing electrode 10-10p before the corresponding input of corresponding A/D converter 1110a-p is received at first can with being similar to above about Fig. 9 and 10 described modes be cushioned, filtering and/or amplification be not so that A/D converter makes corresponding ECG sensing electrode overload, and any frequency component of assurance received signals is lower than the Nyquist frequency of corresponding A/D converter 1110a-p.

The embodiment of the Figure 10 that is arranged in parallel with a plurality of A/D converter 1010a-p wherein compares, and each of a plurality of A/D converter 1110a-p of this embodiment is for example via universal serial bus (SPI for example^TMUniversal serial bus, ASPT^TMUniversal serial bus or Microwire^TMUniversal serial bus) (or cascade) is one another in series.Each corresponding A/D converter 1110a-p is arranged to during the first period sampling from corresponding one signal of a plurality of ECG sensing electrode 10a-p, and during the follow-up period is digital signal with conversion of signals and the digital signal through conversion offered next A/D converter in the chain.The output of last A/D converter 1110p in the chain is via communication link 1120(universal serial bus for example) be coupled to communicatedly at least one processor.Therefore the output of the last A/D converter (for example A/D converter 1110p) in the chain offers at least one processor 410 with multibit signal, not coordination in the multibit signal is corresponding to different ECG sensing electrodes, for example, the First Series of position is corresponding to the digital signal through conversion that obtains from ECG sensing electrode 10p, the second series of position is corresponding to the digital signal through conversion that obtains from ECG sensing electrode 10o, and the last series of position is corresponding to the digital signal through conversion that obtains from ECG sensing electrode 10a.

In order to guarantee enough resolution, each of a plurality of A/D converter 1110a-p can be 24 A/D converters, has the still less A/D converter of position, for example 16 but can alternatively use.Compare about the described embodiment of Fig. 9 with top, and be similar to top about the described embodiment of Figure 10, each of a plurality of A/D converter 1110a-p of this embodiment does not need to have the N sample rate doubly of the expectation sample rate that is the ECG signal, wherein N is the quantity of the ECG sensing electrode of expectation monitoring, and reason is each of the signal that receives from corresponding ECG sensing electrode of can sampling concurrently.Therefore, in the situation of the ECG signal that expectation is provided by three right each of ECG sensing electrode with the monitoring of particular sample rate, each of a plurality of A/D converters can with identical sample rate operation, allow the use of the lower A/D converter of cost thus.Yet, because a plurality of A/D converter 1110a-p are cascaded, therefore the speed that passes to the next one and then pass at least one processor 410 from A/D converter through the digital signal of conversion should be the ECG signal the expectation sample rate at least N doubly, wherein N is corresponding to the quantity of the ECG sensing electrode of expectation monitoring.The A/D converter of the adequate types of in the above described manner cascade or series connection is the MAX11040K(24 position that can obtain from the Maxim Integrated Products company in California Sen Niweier city (Sunnyvale)) or the MAX11060(16 position) ADC, can be from other analog-digital converter of other company's acquisition but can alternatively use.

According to this embodiment, at least oneprocessor 410 control signal can be sent to a plurality of A/D converter 1110a-p each with at roughly the same period sampling corresponding signal, and then will be sampled and send to next A/D converter in the chain through the digital signal of conversion at follow-up time.At last, last A/D converter 1110p offers at least oneprocessor 410 with serial bit stream.Depend on that to select in a plurality of ECG sensing electrodes which paired with each other, the digital signal (typically corresponding to the identical period) that at least oneprocessor 410 extracts corresponding to two selected digital signals, anti-phase in them one, and summing signal is digitally carried out with top effectively about functional identical with 3 described differential instrument amplifiers of Fig. 2 A-C.Can carry out to any pairing of ECG sensing electrode and corresponding to the identical or different period and be selected the right selection of digital signal, anti-phase and summation.Then can process digital summing signal with monitoring patient's ECG signal and/or detect any arrhythmic heart conditions.

Should understand in the above and be used in the situation of the electrode system related with wearable portable medical device about the described signal acquisition circuit of Fig. 9-11, each of these signal acquisition circuits not only allows to monitor and the ECG signal of analyzing from any pairing of the ECG sensing electrode related with wearable portable medical device, and they also allow a plurality of ECG sensing electrode 10a-p each signal with from the signal of another source (for example wireless ECG sensing electrode) pairing.For example, wireless ECG sensing electrode can be provided, it comprises A/D converter, example any A/D converter 1010a-p described above or 1110a-p, it is coupled to wireless transmitter or transceiver and can communicates by letter with at least one processor 410 via wireless communication protocol (such as bluetooth, ZigBee, Wireless USB, wireless ethernet, GSM etc.).In expectation situation about doing like this, from the signal of wireless ECG sensing electrode then can with from each any signal pairing of the related ECG sensing electrode 10-p of wearable portable medical device.In this mode, if the additional heart information of expectation, additional wireless ECG sensing electrode can place on patient's the health, and monitors and analyze those signals.In fact, in certain embodiments, each of ECG sensing electrode does not need related with the clothes of being dressed by the patient, but each of ECG sensing electrode can be the self-adhering type wireless ECG sensing electrode that places simply as required on patient's the health.

Describe like this some aspects of at least one embodiment of the present invention, should understand those skilled in the art and will expect easily various changes, modification and improvement.It is a part of this disclosure that such change, modification and improvement are intended to, and is intended to be within the scope of the present invention.Therefore, the description of front and accompanying drawing are as just example.

Claims (40)

1. portable medical device, it comprises:

Be configured to be arranged in around a plurality of electrodes of the interval location of patient's health;

Electrode signal Acquisition Circuit with a plurality of inputs, the corresponding input of each of described a plurality of inputs is electrically coupled to the respective electrode of described a plurality of electrodes, and described electrode signal Acquisition Circuit is configured to sensing by a plurality of different corresponding signals that provide that match of described a plurality of electrodes; And

Be electrically coupled to the observation circuit of the output of described electrode signal Acquisition Circuit, described observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one to monitor based on following at least one: by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings, by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings, selecteed at least one respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least one the respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.

2. portable medical device according to claim 1, it comprises also and is configured to the clothes dressed around patient's health that wherein said a plurality of electrodes are incorporated in the described clothes.

3. portable medical device according to claim 2, wherein said a plurality of electrodes are ECG sensing electrodes, and wherein said observation circuit is cardiac monitoring and arrhythmia detection circuit.

4. portable medical device according to claim 3, wherein said a plurality of ECG sensing electrodes comprise at least three ECG sensing electrodes.

5. portable medical device according to claim 4, wherein said a plurality of ECG sensing electrodes all are not arranged in common plane.

6. portable medical device according to claim 5, wherein said cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings.

7. portable medical device according to claim 6, it also comprises:

A plurality of therapeutic electrodes, described a plurality of therapeutic electrodes are incorporated in the described clothes, and are configured to respond by described cardiac monitoring and arrhythmia detection electric circuit inspection to the health that can treat cardiac arrhythmia defibrillation shock is transported to the patient.

8. portable medical device according to claim 5, wherein said cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by the plane that selecteed at least one the respective electrode in described a plurality of different pairings limits.

9. portable medical device according to claim 5, wherein said cardiac monitoring and arrhythmia detection circuit are configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, to monitor with respect to the cardiac cycle of the position of patient's health and patient's heart based on selecteed at least one the respective electrode in described a plurality of different pairings.

10. portable medical device according to claim 5, wherein said cardiac monitoring and arrhythmia detection circuit are configured to select in described a plurality of different pairings at least three to monitor based on following at least one: by the quality of each selecteed at least three corresponding signal that provides in described a plurality of different pairings, by the phase contrast between each selecteed at least three corresponding signal that provides in described a plurality of different pairings, selecteed at least three respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least three respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.

11. portable medical device according to claim 1, it also comprises the clothes that is configured to around patient's health wearing, wherein said a plurality of electrode is incorporated in the described clothes, and wherein said a plurality of electrode comprises at least four ECG sensing electrodes that all are not arranged in common plane.

12. according to claim 1 with 11 in each described portable medical device, wherein said observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by selecteed at least one corresponding signal that provides in described a plurality of different pairings with by the phase contrast between another selecteed at least one corresponding signal that provides in described a plurality of different pairings.

13. according to claim 1 with 11 in each described portable medical device, wherein said observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, with based on monitoring by the quality of selecteed at least one corresponding signal that provides in described a plurality of different pairings and by the plane that selecteed at least one the respective electrode in described a plurality of different pairings limits.

14. according to claim 1 with 11 in each described portable medical device, wherein said observation circuit is configured to analyze each corresponding signal that provides by described a plurality of different pairings, and indicate described electrode signal Acquisition Circuit to select in described a plurality of different pairings at least one, to monitor with respect to the cardiac cycle of the position of patient's health and patient's heart based on selecteed at least one the respective electrode in described a plurality of different pairings.

15. according to claim 1 with 11 in each described portable medical device, wherein said observation circuit is configured to select in described a plurality of different pairings at least three to monitor based on following at least one: by the quality of each selecteed at least three corresponding signal that provides in described a plurality of different pairings, by the phase contrast between each selecteed at least three corresponding signal that provides in described a plurality of different pairings, selecteed at least three respective electrode in described a plurality of different pairings is with respect to the position of patient's health, the plane that is limited by selecteed at least three respective electrode in described a plurality of different pairings, and the cardiac cycle of patient's heart.

16. portable medical device according to claim 15, wherein said observation circuit is configured to during the first period to select at least two among in described a plurality of different pairings selecteed at least three to monitor, and selects different at least two among in described a plurality of different pairings selecteed at least three to monitor during the second period.

17. portable medical device according to claim 1, wherein said a plurality of electrodes are ECG sensing electrodes, and wherein said observation circuit is cardiac monitoring and arrhythmia detection circuit.

18. portable medical device according to claim 17, wherein said a plurality of ECG sensing electrodes comprise at least three ECG sensing electrodes.

19. portable medical device according to claim 1, wherein said electrode signal Acquisition Circuit comprises:

Select circuit, described selection circuit has a plurality of inputs and a plurality of output, and the corresponding input of each of described a plurality of inputs of described selection circuit is electrically coupled to the respective electrode of described a plurality of electrodes; And

A plurality of differential amplifiers, each corresponding differential amplifier has a pair of input and an output, the corresponding input of each of described a pair of input is electrically coupled to the corresponding output of described a plurality of outputs of described selection circuit, and the corresponding output of each of described a plurality of differential amplifiers provides the output signal corresponding to the difference between the described a pair of input of described corresponding differential amplifier.

20. portable medical device according to claim 1, wherein said electrode signal Acquisition Circuit comprises:

A plurality of differential amplifiers, each has a pair of input and an output, and described a plurality of differential amplifiers comprise the corresponding differential amplifier for each unique pairing of described a plurality of electrodes; And

At least one that select that circuit, described selection circuit be configured to select described a plurality of differential amplifiers exports to offer described observation circuit.

21. portable medical device according to claim 1, wherein said electrode signal Acquisition Circuit comprises:

Have the analog multiplexer of a plurality of inputs and an output, each of described a plurality of inputs is electrically coupled to corresponding in described a plurality of electrode; And

Analog-digital converter, described analog-digital converter has the input of the output that is electrically coupled to described analog multiplexer.

22. portable medical device according to claim 21, the sample rate that wherein said analog-digital converter has are that by at least N of the expectation sample rate of each signal that provides of described a plurality of electrodes doubly wherein N is the quantity with monitored described a plurality of electrodes.

23. portable medical device according to claim 21, wherein said observation circuit comprises at least one processor, described at least one processor is configured to receive corresponding to the first digital signal of the first electrode of described a plurality of electrodes with corresponding to the second digital signal of the second electrode of described a plurality of electrodes, in anti-phase described the first and second digital signals one, and another corresponding signal that provides with the pairing of analyzing by described the first electrode and described the second electrode in described anti-phase and described the first and second digital signals in described the first and second digital signals of suing for peace.

24. portable medical device according to claim 1, wherein said electrode signal Acquisition Circuit comprises a plurality of analog-digital converters, and each corresponding analog-digital converter has corresponding one the corresponding input that is electrically coupled in described a plurality of electrode.

25. portable medical device according to claim 24, each of wherein said a plurality of analog-digital converters is connected in described a plurality of analog-digital converter another by universal serial bus.

26. a method of monitoring the ECG signal, described method comprises following action:

Among a plurality of ECG sensors, select a plurality of differences of ECG sensor to match;

Analysis is by each corresponding ECG signal that provides of described a plurality of different pairings;

Identify in described a plurality of different pairings at least one to monitor based on following at least one: the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings, the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by the phase contrast between another at least one the corresponding ECG signal that provides that is identified in described a plurality of different pairings, the corresponding ECG sensor of described at least one that is identified in described a plurality of different pairings is with respect to the position of patient's health, by the plane of the corresponding ECG sensor definition of described at least one that is identified in described a plurality of different pairings, and the cardiac cycle of patient's heart; And

Monitor described at least one that is identified in described a plurality of different pairings.

27. method according to claim 26, wherein identify at least one action to monitor in described a plurality of different pairings, the corresponding ECG signal that provides based on the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by described at least one that is identified in described a plurality of different pairings and by the phase contrast between another at least one the corresponding ECG signal that provides that is identified in described a plurality of different pairings.

28. method according to claim 27 wherein selects among described a plurality of ECG sensors the actions of a plurality of different pairings of ECG sensor to comprise the action of selecting each unique pairing of ECG sensor among described a plurality of ECG sensors; And action by each corresponding ECG signals that provide of described a plurality of different pairings wherein is provided to be comprised and analyzes the corresponding ECG signal that each the unique pairing by the ECG sensor provides.

29. method according to claim 28, wherein the action of monitoring comprises:

Monitor described at least one that is identified in described a plurality of different pairings to detect cardiac arrhythmia.

30. method according to claim 29, it also comprises following action:

The motion detection cardiac arrhythmia of response monitoring;

Determine that detected cardiac arrhythmia is the type of the cardiac arrhythmia that can treat by the health that defibrillation is applied to the patient; And

At least one defibrillation pulse is applied to patient's health.

31. method according to claim 29, it also comprises following action:

The motion detection cardiac arrhythmia of response monitoring;

Response detects at least one additional pairing that cardiac arrhythmia is selected the ECG sensor, and the corresponding ECG signal that is provided by described at least one additional pairing is provided;

Determine that detected cardiac arrhythmia also is present on the corresponding ECG signal of described at least one additional pairing;

Determine that detected cardiac arrhythmia is the type of the cardiac arrhythmia that can treat by the health that defibrillation is applied to the patient; And

At least one defibrillation pulse is applied to patient's health.

32. method according to claim 29, it also comprises following action:

The motion detection cardiac arrhythmia of response monitoring;

Response detects at least one additional pairing that cardiac arrhythmia is selected the ECG sensor, and the corresponding ECG signal that is provided by described at least one additional pairing is provided;

Determine that detected cardiac arrhythmia also is present on the corresponding ECG signal of described at least one additional pairing; And

Increase the confidence level that has detected cardiac arrhythmia.

33. method according to claim 29, it also comprises following action:

The motion detection cardiac arrhythmia of response monitoring;

Response detects at least one additional pairing that cardiac arrhythmia is selected the ECG sensor, and the corresponding ECG signal that is provided by described at least one additional pairing is provided;

Determine that detected cardiac arrhythmia is not present on the corresponding ECG signal of described at least one additional pairing; And

Reduce to detect the confidence level of cardiac arrhythmia.

34. according to claim 26 with 27 in each described method, wherein repeat the action of described selection, analysis and identification with periodic intervals.

35. according to claim 26 with 27 in each described method, wherein said a plurality of ECG sensor is incorporated in the clothes of patient's health wearing, and wherein carries out the action of described selection, analysis and identification when patient's health is placed whenever described clothes.

36. according to claim 26 with 27 in each described method, wherein said a plurality of ECG sensors are incorporated in the clothes of dressing around patient's health, described method also comprises following action:

Detect patient's violent body movement; And

The action of response detection patient's aggravating activities repeats the action of described selection, analysis and identification.

37. method according to claim 27, it also comprises following action:

The quality of determining the corresponding ECG signal that the first pairing by the ECG sensor of described at least one that is identified in described a plurality of different pairings provides is lower than definite threshold;

Select the first pairing of another pairing replacement ECG sensor of ECG sensor; And

Another pairing of monitoring ECG sensor.

38. according to claim 26 with 27 in each described method, it also comprises following action:

The quality of the corresponding ECG signal that the first pairing of the ECG sensor of described at least one that is identified from matched by described a plurality of differences provides determines that one or more may the losing with patient's health at least in part in the described first ECG sensor that matches contacts;

Select the first pairing of another pairing replacement ECG sensor of ECG sensor; And

Another pairing of monitoring ECG sensor.

39. method according to claim 26, wherein identify at least one action to monitor in described a plurality of difference pairing, the plane of the corresponding ECG sensor definition of described at least one that is identified in matching based on the quality of the corresponding ECG signal that is provided by described at least one that is identified in described a plurality of different pairings and by described a plurality of differences.

40. method according to claim 26, wherein identify at least one action to monitor in described a plurality of different pairings, based on the corresponding ECG sensor of described at least one that is identified in the described a plurality of different pairings cardiac cycle with respect to the position of patient's health and patient's heart.

Images